A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: Olorofim

• Registration Number: NCT05200286
• Lead Sponsor: F2G Biotech GmbH

Brief Summary

A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-20
• Study Start: 2022-02-10
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
• Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive)
• Subjects with severe renal impairment (or End-Stage Renal Disease who are not on dialysis) and with an eGFR <30 mL/min, estimated using the Cockcroft-Gault equation at screening and Day -1
• Subjects with normal renal function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
• Subjects with normal renal function are matched by gender, age (±10 years) and BMI (± 20%) to at least one renally impaired subject.

Exclusion Criteria

• Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
• Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
• Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
• Subjects with a history of or any concomitant active malignancy.
• Subjects with a history of drug or alcohol abuse.
• Subjects with, or with a history of, any clinically significant neurological, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the Investigator.
• Subjects with signs or symptoms consistent with a COVID-19 infection at screening or Day -1
• Renally impaired subjects with kidney transplantation, or on dialysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe renal impairment	Olorofim	120 mg olorofim
Normal renal function	Olorofim	120 mg olorofim

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	0-96 hours
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)	0-96 hours

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events	10 days
Time to Reach Maximum Plasma Concentration (Tmax)	0-96 hours
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)	0-96 hours
Apparent Elimination Half Life (t1/2)	0-96 hours

Trial Locations

Locations (1)

Omega Research; 🇺🇸 Orlando, Florida, United States